MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 22nd january 2026, it was reported by an arthrex employee via email that ar-8991 dx fibertak suture anchor, #2 mts w/ ndl, batch 15420715, had pulled out from the fibula bone socket during the final tensioning of the extensor retinaculum to the fibula in a procedure performed on the same day.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24312693
• Report Number: 1220246-2026-00520
• Device Sequence Number: 14845935
• Product Code: MBI
• UDI-Device Identifier: 00888867377295
• UDI-Public: (01)00888867377295(11)250415(17)300331(10)15420715
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
• Device Catalogue Number: AR-8991
• Device Lot Number: 15420715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown